N/A
Completed N=24
Open-Label Study for Shoulder Dislocation Using MG-1
Source: ClinicalTrials.gov NCT01528319 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
Aug 2014
Primary outcomePrimary: Surgery Success — 23 participants
Summary
To evaluate the efficacy and safety of arthroscopic Bankart repair using MG-1 for dislocation of shoulder
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgery Success |
23 | — |
| PRIMARY Clinical Function Evaluation |
82.7; 88.9 | — |
| SECONDARY Procedure Success |
23 | — |
| SECONDARY Clinical Function Evaluation |
82.7; 88.9 | — |
| SECONDARY Number of Participants With Abnormal Changes in One or More Laboratory Tests |
1 | — |
| SECONDARY Adverse Event Evaluation |
18 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with dislocation of the shoulder and indicated for arthroscopic Bankart repair
- Patients of 16 years or older
- Patients who understand the contents of the study and from whom a written consent can be obtained
- Patients who can visit the hospital for follow-ups after surgery
Exclusion Criteria
- Patients with serious complications
- Patients with comminuted fracture which may prevent fixation of the anchors
- Patients with the following diseases or conditions which may delay healing
- Lack of blood, infection, etc.
- Psychiatric disorder, alcohol poisoning, drug toxicity, etc.
- Tissues around the surgical site are not healthy under steroid therapy or chemotherapy
- Patients with epilepsy or bone disease (cystic change, osteopenia, etc.)
- Patients with dementia
- Patients with a history of allergy to glycolic acid, poly-L-lactic acid, β-tricalcium phosphate, polyethylene or polydioxane
- Patients who cannot undergo general anesthesia
- Patients who cannot undergo plain X-ray examination or MRI examination
- Patients with previous bone grafting in the shoulder joint
- Patients who participated in another clinical trial within past 3 months
- Patients who are pregnant or lactating. Patients who plan to be pregnant within a year
- Patients judged to be inappropriate for the study by the (sub)investigator
Data sourced from ClinicalTrials.gov (NCT01528319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.